Outsourcing Drug Trials

Outsourcing has become a well-tried practice in the global economy. Outsourcing manufacturing is a strategy that has become very widespread. Outsourcing services, illustrated by India’s call-centers, is more recent but has become common practice for many western multinationals. Even the more knowledge intensive services like accounting are now often being provided overseas. India currently is even becoming increasingly a recipient of outsourced R&D. Even waste management and recycling is outsourced nowadays.

But this article in Wired Magazine gave me another view on outsourcing, and one that increasingly worried me reading through the article. It is about a new outsourcing boom in South Asia: the outsourcing of drug trials. Drug trials in the West are becoming problematic because less people want to participate in the trials, the amount of drugs to be tested increases and because the trials generally take a long time:

Like many in the pharmaceutical industry, Narula (medical director of a contract-research firm that organizes trials for major multinational) believes that the solution to the slow pace of drug trials lies in outsourcing. As many as half of all clinical trials are already conducted in locations far from the pharmaceutical companies’ home base, in countries like India, China, and Brazil. And many industry analysts expect the market to skyrocket, particularly as expanding libraries of genetic information increase the number of drugs coming out of the lab. The consulting firm McKinsey calculates that the market in India for outsourcing trials will hit $1.5 billion by 2010.

Ofcourse, the trials bring along benefits. Obviously, the hospitals receive resources that they desperately need. Second, it can be a form of knowledge transfer. However, Kalantri (a local doctor involved in one of such trials) clearly points to problems related to corruption and to the naivety of many of the patients (which come predominantly from the poorer segments of society). Another important point is that the medicines tested are not the ones that are most needed in those countries. And if they are needed, they will be unaffordable for those patients.

When the trial ended, however, Kalantri wondered whether he had served his patients well by enrolling them. At 800 rupees a day, the drug they had taken was too expensive for any of them to afford. Plus, even when it worked, it showed results for just a month. Such a minute and costly improvement might make sense in the US, Kalantri felt, but was it really the kind of medication that poor Indians should be testing? “The biggest problems around here are snakebite and insecticide poisoning,” he points out. “We could really use a trial for one of those.” He mentioned that the emergency ward contained a number of patients with a mysterious fever, one that epidemiological tests had been unable to identify. “It would be good to study it,” Kalantri murmured, sounding a bit regretful. “Maybe we will, one day.”

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This is a very interesting article – I never thought drug trial could be outsourced too.

I share the same concern as you that the appropriate measures and due process may not have been followed when carrying out these trial in asian countries. In recent event in UK, a drug trial went wrong (the “elephant man incident”) and the drug company pretty much went bust. In Asia, this may just be written off.

Unfortunately, the solution may have to come from the west – FDA etc requiring pharmacheutical firm to take equal level of precaution even if the trial takes place aboard.

Another issue may be that as the environment, diet, phsyical attributes of the sibjects are different, the result may not been 100% accurate.